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The HSC is LBNL's IRB and meets once a month. The committee is made up of staff scientists and communitiy community members and considers any research at LBNL involving humans or human tissues. Federal regulations concerning scientific research using human subjects may be found at http://www.science.doe.gov/ober/humsubj/regulation.html.
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The HARC office has an online database for managing human subjects protocols: the Human/Animal Research Protocol management system, or HARP. Researchers submitting new protocols or wanting to renew or amend already approved protocols must use the new system. If you are on an LBNL computer,and logged into anything (email, calendar, etc.) where you have already typed in your LDAP password, the HARP system can be accessed through opening a web page a typing in the url goapp/harp. Or you may use this link. If you are on a non-LBNL computer, you can get access from offsite either by logging on to your LBNL computer remotely, or through the use of Virtual Private Network (VPN) software, available to LBNL employees form the IT Division website. This is still a relatively new system and we appreciate your patience during our roll-out. You may call the HARC office at x5399 or send email to [email protected] with any questions. This frequently asked questions document may be of some use to you.
All principle lead investigators and their responsible research staff named in the protocol must have an account on the HARP system. The HARC staff are currently setting up new accounts. Please send us all the information requested in this role and account information document to [email protected].
Please note that to renew or amend an older protocol, you must first enter all the information in that old protocol as a new submission to the HARP system, including uploading as attached documents all consent forms, recruitment flyers, etc. In most cases the HARC staff will be able to accept this old version of the protocol for initiation within one or two days. Researchers should then proceed to use the HARP system to submit their renewal and/or amendment. That renewal or amendment submission will be treated as deemed necessary by the HARC staff, either treated as expeditable or taken to the full Human Subjects Committee for consideration at its next regularly scheduled meeting. Although this may seem like a major inconvenience, even a very complicated protocol can be fed into the HARP system and submitted for intitial acceptance in under an hour.The HARC staff believes that LBNL researchers will find the renewal process quick and easy.
There are several basic types of human subjects protocols. They are described below. The HARP system will step you through the definitions and submission processes once you enter it.
Exempt protocols Research involving pre-existing human data or tissues with no identifying information attached will typically be exempt from needing a full protocol. In fact, if tissues are obtained from a federally assured public tissue bank no review of any kind may be needed. If you think your research may qualify as not human use, please call the HARC office at 510/486-5399 to discuss this with Chris Byrne or Dianna Bolt. An exemption is needed then, if you do not already have a HARP account, please fill out this form and form and send it as an email attachment to [email protected]. Once you have an account please enter the HARP system and proceed to follow instructions for submitting an exempt protocol.
Non-exempt research If in your research you will be using human tissues or collecting data of any sort from identifable sources, then you must complete the full protocol process (see below). Possible scenarios: 1) you will be receiving encoded samples from collaborators at other institutions such that the identity of the subject tissue donors is unknown to you. If, however, you will be returning tissues, or data to your collaborators at those institutions, and especially if any part of this information will be returned to the subjects, then you must complete a full protocol. 2) Or you may be conducting an energy study of low risk in subjects' homes or at their work, sampling air quality, or testing whether a new appliance works more efficiently. If these or similar scenarios describe your work, then your protocol may be judged by the HARC office and the Human Subjects Committee and its policies to be expeditable, but you will still need to file a non-exempt protocol in HARP. Fill out this formand and send it as an email attachment to [email protected]. Once you have an account please enter the HARP system and proceed to follow instructions for submitting an expedited protocol. Please note that you will need to upload into the HARP sytem system a copy of the collaborating institution's currently approved protocol(s), including consent form(s) and proof of approval. Any questions should be directed to HARC office staff at x5399.
Full If the research you are planning to conduct at LBNL involves interaction with human subjects, then you must submit a detailed protocol outlining the nature of the research, recruitment of subjects, procedures to be used, storage of data, etc. In other words, you need full review of your protocol, your consent form(s), your recruitment flyer or letter, and any other materials relevant to protecting the health, safety, and confidentiality of your human subjects. If you and all of your responsible staff members do not already have an account on the HARP system, please fill out this form for all relevant personnel and send it as an email attachment to [email protected]. Once you have all needed accounts please enter the HARP system and proceed to follow instructions for submitting a full protocol. Please feel free to call the HARC office at x5399 for any help you may need with this.
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One concern with writing consent forms is that they should be written to be understandable by a potential subject with a 10th grade reading level. This can be quite a challenge if one is dealing with medical or scientific terminology. We have available a glossary of lay terminology which can be useful in "translating" medical terms into more commonly used language.
You should also attach a copy of the California Medical Research Subject's Bill of Rights to your consent form.
- Consent form checklist
- General consent form outline
- Routine phlebotomy/blood draw consent form model
- Biomedical procedures consent form model
- California Medical Research Subject's Bill of Rights
Collaborative and other non-exempt research If your research involves receiving encoded samples from collaborators at other institutions, or at LBNL, such that the identity of the subject tissue donors is unknown to you and you will be returning tissues, or data to your collaborators at those institutions, and especially if any part of this information will be returned to the subjects, then you must submit your protocol through the HARP system to submit it as an Expedited Verfication Assessment or EVA. You must also submit (upload into HARP) a copy of the collaborating institution's currently approved protocol(s), including consent form(s) and proof of approval.
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Working with another UC campus: If you will be relying on the review of another University of California's IRB, please use the NOITR (Notice of Intent to Rely) path in the HARP system. Basically the paperwork for the other UC's IRB must be done first and filed there. Once the reviewing IRB has approved the complete application, that campus should send a copy of the signed NOITR you, which you will upload it with your submission in the HARP system. Please call HARC officer staff at 510/486-5399 if you have any questions, or send them email at [email protected].
